Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062644) titled 'A birth cohort observational study of skin factors associated with the development of infantile atopic dermatitis' on Aug. 21.

Study Type: Observational

Primary Sponsor: Institute - The University of Osaka

Condition: Condition - Infantile atopic dermatitis and food allergy Classification by malignancy - Others Genomic information - YES

Objective: Narrative objectives1 - To longitudinally assess skin manifestations, skin barrier function, skin microbiota, skin lipids, allergen sensitization, vitamin D, and other immune-related markers from birth to 12 months of age; to identify maternal, infant, and environmental factors associated with the development of atopic dermatitis and food allergy; and to explore targets for prevention. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - [Pregnant women] 1) Continuation of antenatal care and planned delivery and postpartum checkups at a participating institution; 2) age 20 to <45 years at consent; 3) <36 weeks of gestation at consent; 4) written informed consent after adequate explanation; and 5) planned use of the standard skin-care regimen of the institution. [Infants] Full-term infants whose legally authorized representatives provide written informed consent after adequate explanation. Key exclusion criteria - 1) Withdrawal of consent; 2) preterm birth or birth weight <2,500 g; 3) admission of the infant to a neonatal intensive care unit; or 4) any other condition judged by the investigator to make participation inappropriate. Target Size - 400

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 10 Month 15 Day Date of IRB - 2026 Year 02 Month 17 Day Anticipated trial start date - 2026 Year 02 Month 18 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071705

Disclaimer: Curated by HT Syndication.